Sedation Techniques for Outpatient Colonoscopy

National University of Malaysia (UKM)

Status and phase: Completed; Phase 3

Conditions: Colonoscopy

Treatments: Device: target controlled infusion pump; Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection; Drug: Propofol 10 MG/ML Injection; Device: patient-controlled sedation pump; Drug: Midazolam injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04686058

FF-2014-203

Details and patient eligibility

About

This was a prospective, randomized, single-blind controlled clinical trial comparing three sedative regimens for outpatient colonoscopy.

Full description

This was a prospective, randomized, single-blind controlled clinical trial comparing target-controlled infusion (TCI) with propofol and patient-controlled sedation (PCS) with propofol, to conventional combination of midazolam and pethidine, in terms of quality and safety of sedation, and patient recovery during outpatient colonoscopy.

Enrollment: 105 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA I or II patients
• aged between 18 to 80 years
• scheduled for outpatient colonoscopy

Exclusion criteria

• history of or with psychiatric disease
• on psychoactive drugs
• mentally or physically unable to use the hand-held device for PCS
• previous complications from anaesthesia or sedation
• potentially difficult airway maintenance
• obstructive sleep apnoea
• pregnant
• with contraindications to the study drugs

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups

TCI propofol

Active Comparator group

Description:

Target controlled infusion propofol titrated by the investigator intra-procedure, based on the Modified Observer's Assessment of Alertness and Sedation Scale

Treatment:

Drug: Propofol 10 MG/ML Injection

Device: target controlled infusion pump

PCS propofol

Active Comparator group

Description:

Patient-controlled sedation titrated by the patient to comfort level

Treatment:

Device: patient-controlled sedation pump

Drug: Propofol 10 MG/ML Injection

midazolam and pethidine

Active Comparator group

Description:

Midazolam and pethidine bolus doses administered by the investigator based on clinical parameters and observation

Treatment:

Drug: Midazolam injection

Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection